PT  - JOURNAL ARTICLE
AU  - Brazeau, Daphnée
AU  - Deshaies, Amelie A
AU  - Williamson, David
AU  - Bernard, Francis
AU  - Arbour, Caroline
AU  - Pinard, Anne Marie
AU  - Rouleau, Dominique
AU  - De Beaumont, Louis
TI  - Impact of an acute 1-month cannabidiol treatment on pain and inflammation after a long bone fracture: a triple-blind randomised, placebo-controlled, clinical trial protocol
AID  - 10.1136/bmjopen-2024-092919
DP  - 2025 Feb 01
TA  - BMJ Open
PG  - e092919
VI  - 15
IP  - 2
4099  - http://bmjopen.bmj.com/content/15/2/e092919.short
4100  - http://bmjopen.bmj.com/content/15/2/e092919.full
SO  - BMJ Open2025 Feb 01; 15
AB  - Introduction Acute pain levels following orthopaedic injury (eg, fracture) are a predictor of the onset of chronic pain, which affects nearly 50% of fracture patients and impairs functional recovery. Among current pharmacological treatments for acute pain, non-steroidal anti-inflammatory drugs have been associated with delayed bone healing, while opioids inhibit effective bone remodelling, increase the risk of pseudarthrosis and carry a high risk of addiction. In light of this, the development of new pain treatments is essential. Cannabidiol (CBD), a non-addictive and non-psychotropic cannabis component stands out as a potential therapeutic agent, given its analgesic and anti-inflammatory properties as well as its potential benefits for bone healing. This randomised controlled trial aims to investigate the effect of acute CBD treatment, compared with placebo, on patients’ self-reported pain, inflammation and well-being following a fracture injury.Methods and analysis This is a triple-blind, randomised, placebo-controlled clinical trial. A total of 225 adults aged 18–70 years, who have suffered a long bone fracture and were treated at the Hôpital du Sacré-Coeur de Montréal, will be randomly assigned within 1 week to one of three treatment arms (25 mg or 50 mg of CBD or placebo) for 1 month. The primary outcome will be the difference in the pain score between groups at 1-month follow-up. Secondary outcomes will include measures of persistent pain, inflammation, opioid usage, quality of life, sleep quality, depression, anxiety, cognition and orthopaedic function. Data will be collected at baseline, 1-month and 3-month follow-ups.Ethics and dissemination This study obtained a Health Canada licence for use of cannabis products. It has also been approved by Health Canada and the Research Ethics Board of the CIUSSS du Nord-de-l’Île-de-Montréal (Project ID 2025-2105). The findings will be published in a peer-reviewed journal and presented at local, national and international conferences. The trial’s results will be made publicly available on the ClinicalTrials.gov database.Trial registration number NCT06448923.